Evidence map›Paper›PMID 33722897›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2021

Phase I/II Trial of Exemestane, Ribociclib, and Everolimus in Women with HR

Aditya Bardia, Sara A Hurvitz, Angela DeMichele, Amy S Clark, Amelia Zelnak, Denise A Yardley, Meghan Karuturi, Tara Sanft, Sibel Blau, Lowell Hart and 4 more

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 88 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed, 3 pooled it
11.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

88 citing papers in PubMed, 3 syntheses or guidelines pooled it, 111 citations in OpenAlex.

  1. Pooled it
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  9. Palbociclib Rechallenge for Hormone Receptor-Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Trial
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  15. Review of ctDNA in breast cancer - present utility and future perspectives.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2026
    Review
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28 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 12 institutions in 1 country.

Aditya BardiaMassachusetts General Hospital Cancer Center, Harvard Medical School, Boston, Massachusetts. bardia.aditya@mgh.harvard.edu.
Sara A HurvitzUCLA Jonsson Comprehensive Cancer Center, Los Angeles, California.
Angela DeMicheleUniversity of Pennsylvania Abramson Cancer Center, Philadelphia, Philadelphia.ORCID 0000-0003-1297-4251
Amy S ClarkUniversity of Pennsylvania Abramson Cancer Center, Philadelphia, Philadelphia.
Amelia ZelnakNorthside Hospital Cancer Institute, Atlanta, Georgia.
Denise A YardleySarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, Tennessee.
Meghan KaruturiThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Tara SanftYale University School of Medicine, New Haven, Connecticut.
Sibel BlauNorthwest Medical Specialties, PLLC, Puyallup, Washington.
Lowell HartFlorida Cancer Specialists, Fort Myers, Florida.
Cynthia MaWashington University School of Medicine, St Louis, Missouri.
Hope S RugoUCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.
Das PurkayasthaNovartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Stacy MoulderThe University of Texas MD Anderson Cancer Center, Houston, Texas.
The University of Texas MD Anderson Cancer Center · USUniversity of Pennsylvania · USComprehensive Blood & Cancer Center · USFlorida Cancer Specialists & Research Institute · USMassachusetts General Hospital · USNorthside Hospital · USNorthwest Medical Specialties · USNovartis (United States) · USTennessee Oncology · USUCSF Helen Diller Family Comprehensive Cancer Center · USUniversity of Missouri–St. Louis · USYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Dana Farber/Harvard Cancer Consortium Career Development Program in Clinical OncologyK12CA087723 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI David Tsai Ting · 2002 to 2026
$17.9M
NCATS NIH HHS UL1 TR001863NCI NIH HHS K12 CA087723
6 · The paper itself

Abstract

purposeStandard-of-care treatment for metastatic hormone receptor-positive (HR PATIENTS AND

methodsThis multicenter, open-label, single-arm, phase I/II study included patients with locally advanced/metastatic HR

resultsOf 104 patients enrolled (phases I and II), 96 had prior CDK4/6i. Recommended phase II doses (all once daily days 1-28 of 28-day cycle) were ribociclib 300 mg, everolimus 2.5 mg, and exemestane 25 mg (group 1) and ribociclib 200 mg, everolimus 5 mg, and exemestane 25 mg (group 2). CBR among 95 efficacy-evaluable patients (phases I and II) at week 24 was 41.1% (95% confidence interval, 31.1-51.6), which met the primary endpoint (predetermined threshold: 10%). Common adverse events included neutropenia (69.2%) and stomatitis (40.4%). No new safety signals were observed; no grade 3/4 QTc prolongation was reported.

conclusionsPreliminary TRINITI-1 safety and efficacy results support further investigation of CDK4/6 blockade and targeting of the PI3K/AKT/mTOR signaling pathway in patients with ET-refractory HR

Indexed as

AdultAgedAged, 80 and overAminopyridinesAndrostadienesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6Disease ProgressionErb-b2 Receptor Tyrosine KinasesEverolimusFemaleHumansMiddle AgedPurinesAminopyridinesAndrostadienesCDK4 protein, humanCDK6 protein, humanCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6Erb-b2 Receptor Tyrosine KinasesEverolimusexemestanePurinesribociclib

Identifiers

PMID33722897
PMCPMC8487593
OpenAlexW3137610496

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.